Fischl M, Greenberg S, Clumeck N, Peters B, Rubio R, Gould J, Boone G, West M, Spreen B, Lafon S; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 6th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 6th 1999 Chic Ill. 1999 Jan 31-Feb 4; 6th: 70 (abstract no. 19).
University of Miami, FL.
OBJECTIVES: Assess the safety and efficacy of ABC/3TC/ZDV for 48 weeks. DESIGN: 173 therapy-naive pts were randomized to double-blind ABC/3TC/ZDV or 3TC/ZDV. At week 16 all pts had the option of switching to open-label ABC/3TC/ZDV. In addition, pts with confirmed vRNA > 400 cps/mL could switch to a new regimen to include ABC and other available antiretroviral (ART) agents. RESULTS: 75% and 35%, respectively in the ABC/3TC/ZDV and 3TC/ZDV groups were event-free (vRNA < 400 cps/mL) at week 16 in the Intent-to-Treat Analysis (p<0.001) with comparable results in the As-Treated Analysis. In the original ABC/3TC/ZDV group (n=83), 74% of the pts remained event-free (<400 cps/mL) at week 48 and only 9% (7) pts reported the addition of ART. In the original 3TC/ZDV dual therapy group (n=81), 70% added other ART. Of these, 73% added ABC only and 27% added ABC plus other ART. The addition of ABC/ART resulted in a subsequent drop of approximately 1 log that was sustained through 48 weeks. There was no significant difference between the 2 treatment groups in CD4 counts over time. The median change in CD4 count from baseline to week 48 was 150 and 152 cells/mm3 for the ABC/3TC/ZDV and 3TC/ZDV groups, respectively. CONCLUSION: In therapy-naive adults, ABC/3TC/ZDV is an effective regimen through 48 weeks. The addition of ABC to 3TC/ZDV at week 16 resulted in a substantive and sustained drop in vRNA through 32 weeks of follow-up.
Publication Types:
Keywords:
- Adult
- CD4 Lymphocyte Count
- Dideoxynucleosides
- HIV-1
- Humans
- Lamivudine
- Zidovudine
- abacavir
Other ID:
UI: 102188636
From Meeting Abstracts